Press Release USFDA Products Approvals For the Qtr ended 31st Mar, 2024
2024-04-01 · Alembic Pharmaceuticals Ltd. · original alembicpharmaceuticals.com ↗
ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 Date: 1st April, 2024 To, The Manager, Department of Corporate Services, BSE Limited P. J. Towers, Dalal Street, Fort, Mumbai – 400 001 BSE Scrip Code: 533573 To, The Manager, Listing Department, National Stock Exchange of India Ltd. ‘Exchange Plaza’, Bandra Kurla Complex, Bandra (E), Mumbai – 400 051 NSE Symbol: APLLTD Dear Sir/Madam, Sub: Alembic Pharmaceuticals receives one US Food & Drug Administration (USFDA) product approval (Tentative) during the quarter ended 31st March, 2024. With reference the captioned subject, this is to inform the exchange that the Company has received one US Food & Drug Administration (USFDA) Product Approval (Tentative) during the quarter ended 31st March, 2024. The summary statement giving brief of the product approval received during the quarter ended 31st March, 2024 is enclosed for your information and records. Alembic has a cumulative total of 1 97 ANDA approvals (170 final approvals and 27 tentative approvals) from USFDA. We request you to kindly take the above on record. Thanking you, Yours faithfully, For Alembic Pharmaceuticals Limited Manisha Saraf Company Secretary Encl: A/a. ALEMBIC PHARMACEUTICALS LIMITED REGD. OFFICE: ALEMBIC ROAD, VADODARA - 390 003. ● TEL: (0265) 2280550, 2280880 ● FAX: (0265) 2281229 Website : www.alembicpharmaceuticals.com ● E-mail : [email protected] ● CIN : L24230GJ2010PLC061123 Annexure Summarised Product Approval received during the quarter ended 31st March, 2024. Product Name Approval Final/ Tentative Innovator Name Brand name Indication* Ribociclib Tablets, 200 mg. Tentative Novartis Pharmaceutica ls Corporation Kisqali Tablets Ribociclib tablet indicated for the treatment of adult patients with hormone receptor (HR) -positive, human epidermal growth factor receptor 2 (HER2) - negative advanced or metastatic breast cancer in combination with an aromatase inhibitor or fulvestrant as initial endocrine-based therapy.
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